Herbal extract products and methods

ABSTRACT

The present invention relates to a product for topical administration in particular, a product for use in the treatment of eczema and psoriasis and other related conditions.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/937,140 filed on Apr. 12, 2011, now allowed, which claims the benefitof PCT/GB2009/000920, filed Apr. 8, 2009, which claims the benefit of GB0806543.5, filed Apr. 10, 2008, the contents of each of which are herebyincorporated herein by express reference thereto.

DESCRIPTION OF INVENTION

The present invention relates to a product for topical administration,preferably in the form of a cream, lotion or ointment. In particular,the present invention relates to a product for topical administrationfor use in the treatment of eczema and psoriasis and other related skinconditions.

Eczema, or dermatitis as it is sometimes called, is a group of skinconditions which can affect all age groups.

In the United Kingdom, up to a ⅕ of all children of school age haveeczema, along with about a 1/12 of the adult population. The severity ofthe disease, eczema, can vary. In mild forms, the skin is dry, hot anditchy, whilst in more severe forms, the skin can become broken and raw,and can actually result in bleeding.

The underlying causes behind eczema are many and varied and aredependent on the type of eczema a person has.

Atopic eczema is thought to be a hereditary condition. To this end, itis postulated that people with atopic eczema are sensitive to allergensin the environment, which are harmless to others. In atopic eczema, thebody's immune system on coming into contact with an allergen overreacts.This results in inflamed, irritated and sore skin. Associated atopicconditions include asthma and hay fever.

Another form of eczema, known as allergic contact dermatitis, is causedby irritants such as chemicals and detergents and allergens such asnickel. As with atopic eczema, the body's immune system overreacts oncoming into contact with an allergen. The resulting allergic reactionoften develops over a period of time, that is, through repeated contactwith the substance giving rise to eczema.

Other forms of eczema include infantile seborrhoeic eczema, adultseborrhoeic eczema, varicose eczema and discoid eczema.

Although there is currently no known cure for eczema, a number oftreatments have been devised with a view to minimising the discomfortand distress associated with eczema.

There are a number of ways to manage eczema, all of which begin with aneffective skin care routine. The most commonly used treatments includethe use of:

Emollients

Emollients are necessary to reduce water loss from the skin, preventingthe dryness normally associated with eczema. By providing a seal orbarrier, the skin is less dry, itchy and more comfortable.

Emollients are available in various forms, including ointments for verydry skin, and creams and lotions for moderate forms of eczema. Someforms of emollients are directly applied to the skin, whilst other formsare used as soap substitutes or can be added to the bath.

One of the problems associated with some emollients already on themarket is that they too may contain ingredients, which can aggravate thecondition and add to an eczema sufferer's discomfort.

Topical Steroids:

When eczema is under control, normally only emollients are used tomanage the condition. However, in flare ups, when the skin becomesinflamed, the use of a steroid cream is widely accepted.

Steroids act by reducing inflammation and are used in most types ofeczema.

Topical steroids come in four different strengths, namely, mild,moderately potent, potent and very potent. The strength of steroid creamthat a doctor prescribes depends on the age of the patient, the severityof the condition, and the size of the area and part of the body to betreated.

Topical steroids are applied thinly to the affected area, as directed bythe prescribing doctor.

One of the disadvantages associated with the use of topical steroids isthat they need to be reviewed regularly and moreover, there are concernsregarding side effects related to the use of steroids.

Oral Steroids:

Oral steroids are prescribed to alleviate the symptoms associated withvery severe forms of eczema.

As with topical steroids, there are concerns vis-à-vis their associatedside effects.

In addition to the above, it is also known to use topicalimmunomodulators to manage the symptoms associated with eczema.

Psoriasis is an immune-mediated, genetic disease manifesting in the skinand/or joints.

The most common type of psoriasis is plaque psoriasis in which patchesof skin, called “lesions”, become inflamed and are covered by silverywhite scale. Psoriasis can be limited to a few lesions or can involvemoderate to large areas of skin. The severity of psoriasis can vary fromperson to person.

As with eczema, although there are a number of treatments, both topicaland systemic, utilised to manage the discomfort caused by the conditionand clear psoriasis for periods of time, there is no known cure.

Other forms of psoriasis include guttate, characterised by smalldot-like lesions; pustular, characterised by weeping lesions and intensescaling; inverse, characterised by intense inflammation; anderythrodermic, characterised by intense shedding and redness of theskin.

Psoriasis is also linked to other forms of diseases including psoriaticarthritis, which is a specific type of arthritis that has been diagnosedin approximately 23% of people who have psoriasis, that is, according tothe Psoriasis Foundation's 2001 benchmark survey. Psoriatic arthritis issimilar to rheumatoid arthritis, but not as severe.

One of the symptoms associated with the condition of psoriasis isitching. One of the simplest ways to control this symptom is by keepingthe skin moisturised, because dry skin can induce and aggravate thissymptom. To date, treatments to manage the condition of psoriasisinclude anti-histamines, steroids, topical antiseptics, topical immunomodulators, anti-depressants and aspirin.

As will be appreciated, there is a need for new compositions andproducts, which are topically administrable and which can alleviate thedistress and discomfort caused by eczema and psoriasis and other relatedskin conditions including those with the symptom of dry itchy skinand/or dry itchy lesions. There is also a need for a new topicallyadministrable product that is less likely to aggravate and/or add to asufferer's symptoms due to its constituents. Furthermore, there is alsoa need for a new topically administrable product, which is not steroidbased.

BRIEF DESCRIPTION OF THE FIGURES

FIGS. 1 and 2 illustrate the test results and charted percentages inredness of an affected area according to an embodiment of the presentdisclosure;

FIGS. 3 and 4 illustrate the test results and charted percentages indiscomfort of an affected area according to an embodiment of the presentdisclosure;

FIGS. 5 and 6 illustrate the test results and charted percentages initchiness of an affected area according to an embodiment of the presentdisclosure;

FIGS. 7 and 8 illustrate the test results and charted percentages inbleeding of an affected area according to an embodiment of the presentdisclosure;

FIGS. 9 and 10 illustrate the test results and charted percentages inhealthiness of skin according to an embodiment of the presentdisclosure; and

FIGS. 11 and 12 illustrate the test results and charted percentages inoverall rating of a product according to an embodiment of the presentdisclosure.

It is believed that the topically administrable product of the presentapplication at least addresses some of the problems associated withknown products which are used to manage the symptoms associated witheczema and psoriasis and other related skin conditions identified above.

In a first aspect of the present invention, there is provided a productfor topical administration which comprises or consists essentially of atleast one moisturising agent selected from the group consisting ofsaccharide isomerate, sodium hyaluronate, phospholipids, biosaccharidegum-1, glycyrrhetinic acid;

-   at least one repairing agent selected from the group consisting of    allantoin, spent grain wax, argania spinosa kernel oil,    butyrospermum parkii (shea butter) extract, and sodium carboxymethyl    beta-glucan; and-   at least one purifying agent selected from the group consisting of    4-terpineol, piroctone olamine; and-   at least one herbal extract selected from the group consisting of    pongamol, Melia Azadirachta extract (preferably leaf extract),    Withania Somnifera extract (preferably root extract), Aloe    Barbadensis extract (preferably leaf juice).

In a second aspect of the present invention there is provided, a productfor topical administration, the product comprising or consistingessentially of herbal extracts or botanical extracts, wherein the herbalextracts include Melia Azadirachta extract (preferably Melia Azadirachtaleaf extract), Withania Somnifera extract (preferably Withania Somniferaroot extract) and Aloe Barbadensis extract (preferably Aloe Barbadensisleaf juice).

In this second aspect, it is preferable that the product furthercomprises or further consists essentially of at least one moisturisingagent selected from the group consisting of saccharide isomerate, sodiumhyaluronate, phospholipids, biosaccharide gum-1, glycyrrhetinic acid;and

-   at least one repairing agent selected from the group consisting of    allantoin, spent grain wax, argania spinosa kernel oil,    butyrospermum parkii (shea butter) extract, and sodium carboxymethyl    beta-glucan; and-   at least one purifying agent selected from the group consisting of    4-terpineol, piroctone olamine.

It is believed that the product of the present invention is less likelyto aggravate the symptoms associated with eczema and psoriasis, notleast because it contains a number of natural herbal or botanicalextracts. It is also believed that the product of the present inventionis less likely to have side effects, not least because it is not steroidbased. It is also believed that the reason why the product of thepresent invention is less likely to aggravate the symptoms of eczema andpsoriasis is because it is not tar or urea based.

Preferred features of the products of the first and second aspect of thepresent invention are as follows:

-   Advantageously, the product of the present invention comprises    saccharide isomerate, sodium hyaluronate, phospholipids,    biosaccharide gum-1, glycyrrhetinic acid; and-   allantoin, spent grain wax, argania spinosa kernel oil,    butyrospermum parkii (shea butter) extract, and sodium carboxymethyl    beta-glucan; and-   4-terpineol, piroctone olamine

Preferably, the Melia Azadirachta leaf extract is present in an amountof 0.01%-2.5% w/w, the Withania Somnifera root extract is present in anamount of 0.01%-2.5% w/w and the Aloe Barbadensis leaf juice is presentin an amount of 0.01%-20% w/w. Further preferably, the Melia Azadirachtaleaf extract is present in an amount of 0.5% w/w, the Withania Somniferaroot extract is present in an amount of 0.45% w/w and the AloeBarbadensis leaf juice is present in an amount of 0.02% w/w.

Advantageously, the product comprises 0.25%-6.0% w/w of saccharideisomerate, 0.005%-0.5% w/w of sodium hyaluronate, 0.005%-1% w/w ofphospholipids, 0.005%-0.8% w/w of biosaccharide gum-1, 0.001%-1% w/w ofglycyrrhetinic acid; and

-   0.1%-5% w/w of allantoin, 0.2%-10% w/w of spent grain wax,    0.1%-20.0% w/w of argania spinosa kernel oil, 0.1%-20% w/w of    butyrospermum parkii (shea butter) extract, and 0.005%-1% w/w of    sodium carboxymethyl beta-glucan; and-   0.05%-5.0% w/w of 4-terpineol, 0.01%-0.5% w/w of piroctone olamine.    More advantageously, the product comprises 2.75% w/w of saccharide    isomerate, 0.1% w/w of sodium hyaluronate, 0.07% w/w of    phospholipids, 0.055% w/w of biosaccharide gum-1, 0.03% w/w of    glycyrrhetinic acid; and-   2.0% w/w of allantoin, 2.0% w/w of spent grain wax, 1.75% w/w of    argania spinosa kernel oil, 1.25% w/w of butyrospermum parkii (shea    butter) extract, and 0.1% w/w of sodium carboxymethyl beta-glucan;    and-   1% w/w of 4-terpineol, 0.5% w/w of piroctone olamine

Preferably, the product of the present invention consists of theingredients set forth in table 1.

Advantageously, the product of the present invention is in the form ofan ointment, a cream or a lotion.

In another aspect of the present invention there is also provided theproduct of the present invention for use in therapy, in particular, foruse in the treatment of eczema or psoriasis or other related skinconditions, including those having the symptom of dry itchy skin and/ordry lesions.

The preferred components of the product of the present invention,together with their sources, are set out below.

Herbal or Botanical Extracts Pongamol

Pongamol which is commercially known as Pongamia extract is extractedfrom the pongam tree (Pongamia Pinnata (L). Pierere). The pongam tree isprimarily cultivated for two purposes, namely, for its fragrantWisteria-like flowers and as a host plant for lac insects.

Well decomposed flowers are used by gardeners as compost for plantsrequiring nutrients. In some countries, the bark of the pongam tree isused for making strings and ropes. The seeds of the tree contain pongamoil, a bitter, red, brown, thick, non-drying, non-edible oil, 27-36% byweight, which is used for tanning leather, soap and as a liniment totreat scabies, herpes, and rheumatism and as an illuminating oil. Theoil has a high content of triglycerides, and its disagreeable taste andodour are due to bitter flavanoid constituents, pongamiin and Karanjin.As will be appreciated, Pongamol has the empirical formula C₁₈ H₁₄ O₄, amolecular weight of 294 and is an off-white cream powder. It is alsoknown to exhibit effective UV absorbing properties.

Melia Azadirachta Leaf Extract

Melia Azadirachta leaf extract, also know as Phytessence Margosa, isextracted from the neem tree, also referred to as the neam tree.

Extracts from the leaves of the margosa tree have been used for a longtime in Indian agriculture and medicine. The plant is well known for itsinsect repellant properties and the therapeutical use of the plant havebeen laid down in classical texts of Ayurveda. The active agentsextracted from the plant are limonoids (salannin) and nimbin (both haveanti-inflammatory properties), sulphurus compounds (antibacterialproperties) and tannins (act as an astringent).

Withania Somnifera Root Extract

Withania Somnifera root extract also known as Indian Ginseng or wintercherry grows as a stout shrub that reaches a height of 170 cm. Like thetomato which belongs to the same family, it bears yellow flowers and redfruit, although its fruit is berry like in size and shape.

Fruits, leaves and seeds of this medicinal plant have been traditionallyused for the Ayurvedic system as aphrodisiacs, diuretics and fortreating memory loss. The active constituents are believed to beanaferine, anahygrine, beta-sisterol, cuscohygrine, iron, pseudotropine,scopoletin, somniferinine, somniferiene, tropanol, withanine,withananine and withanolides A-Y.

Aloe Barbadensis

Aloe vera is a member of the tree lilly family, known asaloebarbadensis.

There are over 250 species of aloe growing around the world. The mostpopular species grown today commercially are aloe barbadensis miller andAloe aborescens.

The following tabulated list of ingredients, which is not comprehensive,is believed to be the most important aloe vera gel ingredients.

Category Typical examples Amino acids Lysine, histidine, arginine,aspartic acid, threonine, serine, hydroxyproline, proline, glycine,alanine, cystine, valine, methionine, isoleucine, leucine, glutamicacid, phenylalanine, tryptophane, tyrosine Enzymes Amylase, kipase,alkaline phosphatae, bradykinase, carboxypeptidase, catalase, oxidaseMinerals Magnesium, calcium, potassium, sodium, phosphorous, zincPhytosterols Beta-Sitosterol, campesterol, lupeol Poly- Glucomannan,acemannan, pectin, cellulose saccharides Vitamins B₁, B₂, B₃, B₆, B₁₂,Folic acid Growth factors Auxins, gibberellins Further active Salicylicacid, malic acid substances

Moisturising Agents

As will be appreciated, moisturising is fundamental for the well beingof the skin and for the integral preservation of intrinsic mechanicalproperties including protection, elasticity, subtleness and plasticity.

Water makes up 70% of the skin and 65% of the epidermis. The epidermisis a stratified epithelium; one of the key functions of which is togenerate a layer of relative impermeable dead cells known as the stratumcorneum.

In order to carry out its role of mechanical, chemical and biologicalprotection, the epidermal barrier must satisfy two conditions; it mustbe compact, but nevertheless remain subtle and it must desquamate veryrapidly in order to permanently retain optimal thickness.

The main stabilising component in this fragile balance lies specificallyin the preservation of a critical moisturising level in the corneallayer, which should be between 10 and 15%.

With the above in mind, and as will be appreciated by those in the art,the term, moisturising agent as used herein, is an agent which at leastmoisturises the skin to the requisite levels. It is also to beappreciated that some of the recited moisturising agents are alsosoothing agents in that they have proven soothing activity (for examplealleviating the discomfort caused by aggressive ingredients such as AHAs(alpha-hydroxy acids), in particular, “in a lactic acid stinging study,Pentavitin® proved to be effective against irritation caused by AHAcontaining products”).

As identified in Table 1, a preferred source of the moisturising agent,saccharide isomerate is Pentavitin®, which corresponds to that of thenatural carbohydrate complex found in the stratum corneum. It is highlysubstantive to skin, and binds itself to keratin thereby creating amoisture reservoir that can only be removed by the natural process ofdesquamation.

Another moisturising agent for use in the present invention is sodiumhyaluronate, which is the sodium salt of hyaluronic acid, aglycosaminoglycan consisting of D-glucuronic acid andN-acetyl-D-glucosamine disaccharide units.

Sodium hyaluronate is extracted from cocks' combs or obtained byfermentation from Streptococci, Lancefield groups A and C. It ispreferably produced by methods of manufacture designed to minimise oreliminate infectious agents. When produced by fermentation ofgram-positive bacteria, the process must be shown to produce oreliminate pyrogenic or inflammatory components of the cell wall.

As identified in Table 1, a suitable source for the phospholipids andglycyrrhetinic acid is glycyrrhetinic acid phytosome, which is complexof soybean extract and glycyrrhetinic acid, namely, a complex of 18β-Glycyrrhetinic acid and soybean phospholipids.

18 β-glycyrrhetinic acid or 3-β hydroxy-11-oxo-olean-12-en-(18-β)-30-oicacid or simply glycyrrhetinic acid is a triterpenic acid obtained fromthe hydrolysis of glycyrrhizic acid; the main component of liquorice(Glycyrrhiza glabra L., family Fabaceae).

It is to be appreciated that the preferred phospholipids isphosphatidylcholine, preferably from soy

As identified in Table 1, one suitable source for the moisturising agentbiosaccharide gum-1 is a product known as Fucogel®, obtainable fromSolabia group (France). In this regard, the polysaccharide biosaccharidegum-1 comprises a repetition of three saccharides, namely, L-fucose,D-galactose and galacturonic acid. The macromolecular structure of thispolysaccharide means it has the ability to form a protective, highlymoisturising film on the surface of the skin. The resulting humanmicroclimate enhances protection of the skin barrier againstdehydration.

Repairing Agents

As will be appreciated, when the skin has been damaged, a set of naturalevents take place to repair the damage, namely, by regenerating theepidermal or epidermal and dermal tissue, that is, dependent on theseverity of the damage. The process of repair is categorised into threeoverlapping phases, namely, the inflammatory phase, the proliferativephase, and the remodelling phase.

In the inflammatory phase, bacteria and debris are phagocytised andremoved and factors are released that cause the migration and divisionof cells involved in the proliferative phase.

The proliferative phase is generally considered to be characterised byangiogenesis, collagen deposition, granulation tissue formation,epithelialisation, and wound contraction. In angiogenesis, new bloodvessels grow from endothelial cells. In fibroplasia and granulationissue formation, fibroblasts grow and form a new, provisionalextracellular matrix by excreting collagen and fibronectin. Inepithelialisation, epithelial cells crawl across the wound bed to coverit. In contraction, the wound is made smaller by the action ofmyofibroblasts, which establish a grip on the wound edges and contractthemselves using a mechanism similar to that in smooth muscle cells.When the cells' roles are close to complete, unneeded cells undergoapoptosis.

In the maturation and remodelling phase, the collagen is remodelled andrealigned along the tension lines and cells that are surplus torequirements undergo apoptosis.

In the light of the above, it is to be understood that in the presentcontext, a “repairing agent” is an agent which plays a part in at leastone of the phases of the healing process set out above.

One of the preferred repairing agents is allantoin. One suitable sourceof this non-allergenic botanical extract, namely, allantoin is thecomfrey root (Symphytum officinale L.). This particular repairing agentpromotes wound healing, speeds up cell regeneration and has a skinsoftening (keratolytic) effect. With specific reference to its woundhealing properties, allantoin clears away dead (necrotic) tissue andhastens the growth of new healthy tissue.

Another preferred repairing agent is spent grain wax (Hordeum Vulgare).The efficacy of spent grain is due to its unique combination ofphysiologically invaluable fatty acids, vitamins and phytosterols. Inparticular, it includes essential fatty acids such as linoleic acid andlinolenic acid, which cannot be synthesised by the human body, but areof vital importance to the skin. Keratinocytes need essential fattyacids, like vitamin F for the biosynthesis of membrane lipids in thehorny layer. Linoleic acid is crucial for the formation and maintenanceof the epidermal permeability barrier. Certain ceramides which areacylated with linoleic acid, strengthen the linkages between lipidbi-layers and the corneocytes. An intact permeability barrier minimisesthe transepidermal water loss thereby protecting the skin from drying.In addition, linoleic acid is the starting material for the biosynthesisof prostaglandins which, for instance, have important immunoregulatoryfunctions and influence epidermal keratinisation. Two major symptomsassociated with essential fatty acid deficiency are epidermalhyperproliferation (scaly skin) and a high level of transepidermal waterloss. However, the essential fatty acids are not the only factorsplaying an important regulatory role in the skin. Fatty acids such aspalmitic, myristic, stearic and oleic acids form lipid double layerswith ceramides and cholesterol, which act as a permeability barrier aswell.

Vitamins play an important role in the delicate equilibrium of the skin.Locally applied vitamins can reverse the degenerative processes relatedto skin aging. In particular, vitamin D stimulates cell respiration andfatty acid metabolism, whereas vitamin E (α-tocopherol) protectsmembranes from oxidative and radical damage (lipid peroxidation) andexhibits anti-inflammatory effects. As a membrane stabilisingantioxidant, it can inhibit the release of histamine and hydroliticenzymes from mast cells and lysosymes. Additionally, vitamin E inhibitsthe synthesis of prostaglandin E₂ , which is known to take part ininflammatory processes.

Phytosterols like β-cytosterol have been shown to improve the epidermalbarrier and to have anti-pruritic effects.

As identified in table 1, a suitable source of the repairing agents,argania spinosa kernel oil and butyrospermum parkii (sheabutter) extractis Stimu-tex® AS (Pentapharm Ltd), which is the commercial name for amultifunctional active compound that treats sensitive, very dry anditchy skin, protecting it from allergic reactions. This product containsspent grain wax obtained by supercritical CO₂ and has a high content oflinoleic acid and phytosterols. As touched upon above, Stimu-tex ® AS,due to its constituents, can alleviate the symptoms of very dry, itchyand irritated skin, protect the skin from allergic reactions, strengthenthe epidermal barrier and exert an anti-inflammatory activity.

Another preferred repairing agent is sodium carboxymethyl beta-glucan,which is a polysaccharide from baker's yeast (Saccharomyces cervisiae)and is a β-(1-3)-linked polyglucose.

Manufacturing Protocol:

One non-limiting example of a process of producing a product inaccordance with the present invention will now be described by way ofreference to Table 2.

EXAMPLE 1

The components of phase A were dispersed in water heated to 80° C. witha vacuum-homogenisator. The components are homogenised under vacuum for45 minutes.

The ingredients of phase B were then added separately at 80° C. and themixture was homogenised for 10 minutes.

The ingredients of phase C were first dissolved and then added andhomogenised under a partial vacuum for 10 minutes.

The ingredients of phase D were added and homogenised for 10 minutesbefore cooling.

The ingredients of phase E were then added to the mixture at 40° C.

At 37° C., the ingredients of phases F, G, H, I, J were then addedseparately.

At 28° C., the maximum of air was withdrawn with a vacuum.

The physico-chemical parameters were controlled and the vessel was thenemptied.

Trials:

With a view to confirming the efficacy of the product of the presentinvention it was subjected to the following trial involving 19participants who all had eczema.

Analysis was conducted on the following trial factors. In particular,for the purpose of analysis, where responses were given on a 9 pointscale, a positive response was considered to score=>5.

The factors considered were as follows:

-   1. Reduction in redness of affected area-   2. Reduction in discomfort of affected area-   3. Reduction in itchiness of affected area-   4. Reduction in bleeding of affected area-   5. Did the product aid healing of skin?-   6. Overall rating of product

1. Reduction in Redness of Affected Area

From a total of 19 recorded responses, 14 participants (74%) reportedthat the product reduced redness. Using binomial, a level ofsignificance of p<0.064 was reached. Test results and chartedpercentages are shown in FIGS. 1 and 2.

2. Reduction in Discomfort of Affected Area

From a total of 19 recorded responses, 14 participants (74%) reported areduction in discomfort of the affected area. Using binomial, a level ofsignificance of 0.064 was reached. Test results and charted percentagesare shown in FIGS. 3 and 4.

3. Reduction in Itchiness of Affected Area

From a total of 19 recorded responses, 14 participants (74%) reportedthat the product reduced itchiness. Using binomial, a level ofsignificance of 0.064 was reached. Test results and charted percentagesare shown in FIGS. 5 and 6.

4. Reduction in Bleeding of Affected Area

From a total of 19 recorded responses, 14 participants (74%) reportedthat the product reduced bleeding in the affected area. Using binomial,a level of significance of 0.064 was reached. Test results and chartedpercentages are shown in FIGS. 7 and 8.

5. Did the Product Aid Healing of Kkin?

From a total of 19 recorded responses, 13 participants (68%) reportedthat the product aided healing and a return to healthy looking skin.Using binomial, a level of significance of 0.167 was reached. Testresults and charted percentages are shown in FIGS. 9 and 10.

6. Overall Rating of Product

From a total of 19 recorded responses, 15 participants (79%) reportedthe product to be effective overall. Using binomial, a level ofsignificance of 0.019 was reached (p<0.02). Analysis therefore supportsthe claim that the product is effective. Test results and chartedpercentages are shown in FIGS. 11 and 12.

As can be seen from the above results, it is clear that the product inaccordance with the present invention is able to alleviate and treat thesymptoms associated with eczema, psoriasis and like skin conditions.

When used in this specification and claims, the terms “comprises” and“comprising” and variations thereof mean that the specified features,steps or integers are included. The terms are not to be interpreted toexclude the presence of other features, steps or components.

The features disclosed in the foregoing description, or the followingclaims, or the accompanying drawings, expressed in their specific formsor in terms of a means for performing the disclosed function, or amethod or process for attaining the disclosed result, as appropriate,may, separately, or in any combination of such features, be utilised forrealising the invention in diverse forms thereof.

TABLE I % w/w % range INGREDIENTS Commercial name Function/CTFAFunction/specific QSP 100% AQUA/WATER Solvent 13.5000000 CAPRYLIC/CAPRICTRIGLYCERIDE Skin-Conditioning component of oil Agent phase 2.9750000GLYCERIN Skin-Conditioning humectant Agent 2.7500000 0.25%-6.0%SACCHARIDE ISOMERATE Pentavitin Skin-Conditioning Moisturising/ Agentsoothing 2.5000000 SUCROSE STEARATE Skin-Conditioning emulsifying agentAgent 2.3970000 ALCOHOL Antifoaming Agent solvent for actives 2.0000000 0.1%-5.0% ALLANTOIN Allantoin Skin-Conditioning Repairing Agent2.0000000  0.2%-10.0% SPENT GRAIN WAX Stimu-tex Skin-ConditioningRepairing Agent 2.0000000 SUCROSE DISTEARATE Skin-Conditioningemulsifying agent Agent 1.7500000  0.1%-20.0% ARGANIA SPINOSA KERNEL OILStimu-tex Skin-Conditioning Repairing Agent 1.2500000  0.1%-20%BUTYROSPERMUM PARKII (SHEA Stimu-tex Biological Additive RepairingBUTTER) EXTRACT 1.0500000 HEXYLENE GLYCOL Solvent 1.0000000 0.05%-5.0%4-TERPINEOL Melaleucol Fragrance Ingredient Purifying 1.00000000.05%-5.0% PONGAMOL Pongamia extract Fragrance Ingredient Herbal extract0.5000000 0.01%-2.5% MELIA AZADIRACHTA LEAF Phytessence MargosaSkin-Conditioning Herbal extract EXTRACT Agent 0.4500000 0.01%-2.5%WITHANIA SOMNIFERA ROOT Withania Somnifera root extractSkin-Conditioning Herbal extract EXTRACT Agent 0.0200000  0.01%-20.0%ALOE BARBADENSIS LEAF JUICE Veragel 200 Skin-Conditioning Herbal extractAgent 0.5000000 GLYCERYL STEARATE Emulsifying Agent component of oilphase 0.5000000 0.01%-0.5% PIROCTONE OLAMINE Octopirox Cosmetic BiocidePurifying 0.4000000 POTASSIUM CETYL PHOSPHATE Surfactant emulsifyingagent 0.3000000 CARBOMER Emulsion Stabilizer gelling agent 0.2650000CAPRYLYL GLYCOL Skin-Conditioning Preservative Agent 0.2500000PHENOXYETHANOL Preservative 0.1000000 0.005%-1.0%  SODIUM CARBOXYMETHYLCM Glucan Binder Repairing BETA-GLUCAN 0.1000000 0.005%-0.5%  SODIUMHYALURONATE Skin-Conditioning Moisturising Agent 0.0700000 0.005%-1.0% PHOSPHOLIPIDS Acide Glycyrrhetinique Skin-Conditioning Moisturising/fitosomes Agent soothing 0.0550000 0.005%-0.8%  BIOSACCHARIDE GUM-1Fucogel Skin-Conditioning Moisturising/ Agent soothing 0.03000000.001%-1.0%  GLYCYRRHETINIC ACID Acide GlycyrrhetiniqueSkin-Conditioning Moisturising/ fitosomes Agent soothing 0.0800000DISODIUM EDTA Chelating Agent 0.0705600 SODIUM HYDROXIDE pH Adjuster0.0503500 CITRIC ACID Chelating Agent/ Part of anti- antioxidant oxidantcomplex 0.0220500 PEG-8 Humectant Part of anti- oxidant complex0.0105000 TOCOPHEROL Antioxidant Part of anti- oxidant complex 0.0017500ASCORBYL PALMITATE Antioxidant Part of anti- oxidant complex 0.0003500ASCORBIC ACID Antioxidant Part of anti- oxidant complex 0.0000128DENATONIUM BENZOATE Denaturant In alcohol SOURCE: INC (InternationalCosmetic Ingredient Dictionary and Handbook - Eleventh Edition 2006)

TABLE 2 Réf CRB Désignation CRB INCI EUROPE + USA + ASIE FournisseurPhase A M06 E010 QSP 100 Eau déminéralisée stérile AQUA/WATER CRB S.A.M09 E180 0.080 Disodium edetate (EDTA) DISODIUM EDTA BRENNTAG-SCHWEIZERHALL M12 G520 3.500 Glycérine 85% Ph. Eur II GLYCERIN CENTONZEEMANUELE AQUA/WATER M17 D789 0.100 Diocide CAPRYLYL GLYCOL DIOW PRODUCTSPHENOXYETHANOL HEXYLENE GLYCOL AQUA/WATER M04 G510 0.100 AcideGlycyrrhétinic Fit. poudre PHOSPHOLIPIDS INDENA GLYCYRRHETINIC ACID M07A075 2.000 Allantoine EP ALLANTOIN SLI CHEMICALS M09 A115 0.100 AcideHyaluronique BT pur (poudre) SODIUM HYALURONATE THERAPO LTD M17 C2560.300 Carbopol Ultrez 10 CARBOMER NOVEON Phase B M07 A555 0.400 AmphisolK POTASSIUM CETYL PHOSPHATE GIVAUDAN M17 S030 2.000 Sisterna SP30-CSUCROSE DISTEARATE SISTERNA BV M17 S070 2.500 Sisterna SP70-C SUCROSESTEARATE SISTERNA BV Phase C M17 C105 9.000 Capric Caprylic TriglycerideCAPRYLIC/CAPRIC TRIGLYCERIDE CENTONZE EMANUELE M07 G580 0.500 Geleol encopeaux GLYCERYL STEARATE GATTEFOSSE M17 S770 5.000 Stimu-tex AS code290-02 SPENT GRAIN WAX PENTAPHARM ARGANIA SPINOSA KERNEL OILBUTYROSPERMUM PARKII (SHEA BUTTER) EXTRACT M17 P670 1.000 Pongamiaextract PONGAMOL QUEST INTERNATIONAL M17 D789 0.100 Diocide CAPRYLYLGLYCOL DIOW PRODUCTS PHENOXYETHANOL HEXYLENE GLYCOL AQUA/WATER M17 O4420.035 Oxynex K liquid PEG-8 MERCK TOCOPHEROL ASCORBYL PALMITATE ASCORBICACID CITRIC ACID Phase D M06 E010 1.000 Eau déminéralisée stérileAQUA/WATER CRB S.A. M14 H859 0.180 Hydroxyde de Sodium 40% (NaOH) SODIUMHYDROXIDE BRENNTAG- AQUA/WATER SCHWEIZERHALL Phase E M17 D789 0.300Diocide CAPRYLYL GLYCOL DIOW PRODUCTS PHENOXYETHANOL HEXYLENE GLYCOLAQUA/WATER Phase F M17 P530 5.000 Phytessence Margosa CAPRYLIC/CAPRICTRIGLYCERIDE CRODA GmbH MELIA AZADIRACHTA LEAF EXTRACT Phase G M06 E01012.000 Eau déminéralisée stérile AQUA/WATER CRB S.A. M12 H420 1.000Hexyléne Glycol art. n° 35008 HEXYLENE GLYCOL BRENNTAG- SCHWEIZERHALLM17 W100 0.450 Withania Somnifera root ext. WITHANIA SOMNIFERA ROOTEXTRACT MMP Inc. M17 V200 0.020 Veragel 200 code TN 003 ALOE BARBADENSISLEAF JUICE TERRY M17 C340 0.100 CM Glucan J SODIUM CARBOXYMETHYLBETA-GLUCAN MIBELLE AG Phase H M17 F015 5.000 Fucogel 1.5 PBIOSACCHARIDE GUM-1 SOLABIA PHENOXYETHANOL AQUA/WATER M06 P410 5.000Pentavitin SACCHARIDE ISOMERATE PENTAPHARM CITRIC ACID AQUA/WATER PhaseI M12 A270 2.550 Alcool Fin F15 ALCOHOL BRENNTAG- DENATONIUM BENZOATESCHWEIZERHALL AQUA/WATER M06 E010 0.450 Eau déminéralisée stérileAQUA/WATER CRB S.A. M17 O140 0.500 Octopirox PIROCTONE OLAMINE CLARIANTGmbH Phase J M17 M240 1.000 Melaleucol 4-TERPINEOL PROVITAL France

What is claimed is:
 1. A therapeutic product adapted for topicaladministration, the product including a mixture of herbal extractscomprising Melia Azadirachta extract present in an amount of 0.01% to2.5% w/w, Withania Somnifera extract present in an amount of 0.01% to2.5% w/w, Aloe Barbadensis extract present in an amount of 0.01% to 20%w/w, or a combination thereof.
 2. The therapeutic product of claim 1,wherein the therapeutic product further comprises: at least onemoisturising agent selected from the group consisting of saccharideisomerate, sodium hyaluronate, phospholipids, biosaccharide gum-1, andglycyrrhetinic acid; at least one repairing agent selected from thegroup consisting of allantoin, spent grain wax, argania spinosa kerneloil, butyrospermum parkii (shea butter) extract, and sodiumcarboxymethyl beta-glucan; and at least one purifying agent selectedfrom the group consisting of 4-terpineol and piroctone olamine.
 3. Thetherapeutic product of claim 2, wherein the at least one moisturisingagent is 0.25% to 6% w/w of saccharide isomerate, 0.005% to 0.5% w/w ofsodium hyaluronate, 0.005% to 1% w/w of phospholipids, 0.005% to 0.8%w/w of biosaccharide gum-1, or 0.001% to 1% w/w of glycyrrhetinic acid;wherein the at least one repairing agent is 0.1% to 5% w/w of allantoin,0.2% to 10% w/w of spent grain wax, 0.1% to 20% w/w of argania spinosakernel oil, 0.1% to 20% w/w of butyrospermum parkii (shea butter)extract, or 0.005% or 1% w/w of sodium carboxymethyl beta-glucan; andwherein the at least one purifying agent is 0.05%to 5% w/w of4-terpineol or 0.01% to 0.5% w/w of piroctone olamine.
 4. Thetherapeutic product of claim 3, which comprises 2.75% w/w of saccharideisomerate, 0.1% w/w of sodium hyaluronate, 0.07% w/w of phospholipids,0.055% w/w of biosaccharide gum-1, 0.03% w/w of glycyrrhetinic acid;2.0% w/w of allantoin, 2.0% w/w of spent grain wax, 1.75% w/w of arganiaspinosa kernel oil, 1.25% w/w of butyrospermum parkii (shea butter)extract, 0.1% w/w of sodium carboxymethyl beta-glucan; 1% w/w of4-terpineol, and 0.5% w/w of piroctone olamine.
 5. The therapeuticproduct of claim 1, wherein the therapeutic product further comprises amoisturising agent that includes 0.25% to 6% w/w of saccharideisomerate, 0.005% to 0.5% w/w of sodium hyaluronate, 0.005% to 1% w/w ofphospholipids, 0.005% to 0.8% w/w of biosaccharide gum-1, and 0.001% to1% w/w of glycyrrhetinic acid; a repairing agent that includes 0.1% to5% w/w of allantoin, 0.2% to 10% w/w of spent grain wax, 0.1% to 20% w/wof argania spinosa kernel oil, 0.1% to 20% w/w of butyrospermum parkii(shea butter) extract, and 0.005% or 1% w/w of sodium carboxymethylbeta-glucan; or a purifying agent that includes 0.05%to 5% w/w of4-terpineol and 0.01% to 0.5% w/w of piroctone olamine.
 6. Thetherapeutic product of claim 1, wherein the Melia Azadirachta extractcomprises Melia Azadirachta leaf extract.
 7. The therapeutic product ofclaim 1, wherein the Withania Somnifera extract comprises WithaniaSomnifera root extract.
 8. The therapeutic product of claim 1, whereinthe Aloe Barbadensis extract comprises Aloe Barbadensis leaf juice. 9.The therapeutic product of claim 1, wherein the herbal mixture comprisesMelia Azadirachta leaf extract, Withania Somnifera root extract, andAloe Barbadensis leaf juice.
 10. The therapeutic product of claim 2,wherein the product is formulated as an ointment or a cream.
 11. Aneczema-treating product comprising the therapeutic product of claim 10.12. A psoriasis-treating product comprising the therapeutic product ofclaim
 10. 13. The therapeutic product of claim 1, wherein the MeliaAzadirachta extract is present in an amount of 0.5% w/w.
 14. Thetherapeutic product of claim 1, wherein the Withania Somnifera extractis present in an amount of 0.45% w/w.
 15. The therapeutic product ofclaim 1, wherein the Aloe Barbadensis extract is present in an amount of0.02% w/w.
 16. A method for treating at least one skin condition, whichcomprises administering a therapeutically effective amount of apharmaceutical composition including an herbal extract comprising MeliaAzadirachta present in an amount of 0.01% to 2.5% w/w, WithaniaSomnifera extract present in an amount of 0.01% to 2.5% w/w, AloeBarbadensis extract present in an amount of 0.01% to 20% w/w, or acombination thereof, to facilitate treatment of the at least one skincondition.
 17. The method of claim 16, wherein the skin condition iseczema.
 18. The method of claim 16, wherein the skin condition ispsoriasis.
 19. The method of claim 18, wherein the pharmaceuticalcomposition comprises at least one moisturising agent selected from thegroup consisting of saccharide isomerate, sodium hyaluronate,phospholipids, biosaccharide gum-1, and glycyrrhetinic acid; at leastone repairing agent selected from the group consisting of allantoin,spent grain wax, argania spinosa kernel oil, butyrospermum parkii (sheabutter) extract, and sodium carboxymethyl beta-glucan; and at least onepurifying agent selected from the group consisting of 4-terpineol andpiroctone olamine.
 20. The method of claim 19, wherein thepharmaceutical composition comprises saccharide isomerate, sodiumhyaluronate, phospholipids, biosaccharide gum-1, glycyrrhetinic acid,allantoin, spent grain wax, argania spinosa kernel oil, butyrospermumparkii (shea butter) extract, sodium carboxymethyl beta-glucan,4-terpineol, and piroctone olamine.
 21. The method of claim 19, whereinthe at least one moisturising agent is 0.25% to 6% w/w of saccharideisomerate, 0.005% to 0.5% w/w of sodium hyaluronate, 0.005% to 1% w/w ofphospholipids, 0.005% to 0.8% w/w of biosaccharide gum-1, or 0.001% to1% w/w of glycyrrhetinic acid; wherein the at least one repairing agentis 0.1% to 5% w/w of allantoin, 0.2% to 10% w/w of spent grain wax, 0.1%to 20% w/w of argania spinosa kernel oil, 0.1% to 20% w/w ofbutyrospermum parkii (shea butter) extract, or 0.005% or 1% w/w ofsodium carboxymethyl beta-glucan; and wherein the at least one purifyingagent is 0.05%to 5% w/w of 4-terpineol or 0.01% to 0.5% w/w of piroctoneolamine.